This Phase IIa, multi-centre, double-blind, randomised, placebo-controlled trial (n=60) will investigate the safety, tolerability, and efficacy of EMP-01 in adults with social anxiety disorder (SAD). Participants will be randomised 1:1 to receive two administrations of either 225 mg EMP-01 or placebo on Day 1 and Day 29, with the primary endpoint assessed at Day 43.
Phase 2, randomized, double-blind, placebo-controlled trial enrolling ~60 adults with DSM-5-TR social anxiety disorder to receive two oral administrations of EMP-01 (225 mg) or matched placebo, 4 weeks apart (Day 1, Day 29).
Primary objective is safety and tolerability; secondary/exploratory objectives include assessment of change in social anxiety symptoms (LSAS, CGI-S) and other clinical measures through Day 43 with monitoring for adverse events.
EMP-01 oral capsules, two administrations (Day 1, Day 29).
EMP-01 capsules (225 mg) per administration
Matched placebo capsules, two administrations.
EMP-01 placebo capsules matched to active